Job title: Clinical Lead

• Location: Cambridge, MA

About the Job

Your skills could be critical in helping our teams accelerate progress. Join our state-of-the-art ECET department as a Clinical Lead, ECET and you'll drive the translation between preclinical development through early clinical development and beyond, while enjoying lots of opportunities to broaden your experience and hone your skills.

This position located within the Translational Medicine Unit (TMU)/Clinical and Patient Sciences (CPS) / Early Clinical and Experimental Therapeutics (ECET) is responsible for ECET contributions across all therapeutic areas at Sanofi and with a scope that includes small molecule, monoclonal antibody, peptide, gene therapy including nucleic acid modalities.

The individual in this position is an integral part of the therapeutic area project teams and cross-functional Translational Medicine Subteam from preclinical development through post-marketing. A key focus of this role is the path from the research phase through early clinical development including early and rapid Proof-of-Mechanism/Proof-of-Concept, as well as natural history studies and experimental model validation to contribute building the Human Target Validation (HTV) and to evaluate the pharmacology of novel therapeutic approaches.

Additionally, to identify potential signals of efficacy or safety notably for new indications and gain better understanding on the mode of action, signal seeking clinical and mechanistic trials are in the scope of expertise for this role. Collaborative interactions with research scientists, toxicologists, pharmacokineticists, modelling & simulation experts, biomarker experts, and late phase therapeutic area clinicians are critical to success in the role. The ability to integrate the outputs of multiple disciplines into a coherent translational medicine and human target validation plan is essential.

Main Responsibilities:

At the project level, the Clinical Lead, ECET will be a member of the Translational Medicine subteam. In these roles, duties include:

• Participate in designing the early development plan and overall ECET plan for the different steps of clinical development, integrating it into the overall development strategy in collaboration with the responsible Therapeutic Area in research and development.
• Design safe, rapid and informative First-In-Human studies including First In Patients, natural history, experimental model validation, mechanistic and signal seeking, streamlined Proof-of-Mechanism as well as Proof-of-Concept studies providing robust data for early Go/No Go decisions, and other pharmacokinetic studies.
• Supervise the execution and ensure close medical monitoring.
• Review, interpret results, and author ECET-related clinical documentation, including informed consent forms, clinical protocols, study reports; some abstracts and/or manuscripts; clinical pharmacology or ECET components of investigator brochures, regulatory documents.
• Interact effectively with managers from various disciplines; serve as expert and internal consultant on assigned area and liaise with partners on projects.
• Participate in the dose selection for First-In-Human studies, drive Go/No Go decisions when needed.
• Ensure an adequate follow-up of studies and project timelines.
• Present data at appropriate meetings (inside or outside Sanofi).

Major Challenges and opportunities:

• Spokesperson of TMU and Clinical Patient Sciences; requires a committed and enthusiastic person to emphasize the strengths of the position and a positive, collaborative mindset.
• Take an active part in the scientific challenges involved in early clinical development, which require a scientifically inquisitive, energetic and proactive person.
• Ensure Clinical Trial standards are maintained at the site and in cooperation with the other clinical functions. Requires excellent communication skills and the implementation of an appropriate process for communication.
• Ensure high-quality documents, requiring strong writing and communication skills.
• Manage aggressive timelines effectively through cross-functional planning.
• Decision Making Authority: Make front-line decisions on protocol design, execution, dose escalation and safety.
• Provide information for Regulatory authorities.

Key Internal/External Relationships:

• Internal contacts: Other TMU departments (mainly PreClinical Safety, Laboratory Sciences, Quantitative Pharmacology, Operations and Evidence Generation & Decision Science), Early Development Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance, Therapeutic Area Research & Development Groups.
• External contacts: Investigators, Clinical Site Services Providers, early phase Clinical Research Organizations, clinical trial vendors, clinical and scientific experts, Key Opinion Leaders, ethics committees, Health Authority representatives.

At the clinical study level, the individual will also serve as Study Medical Manager (SMM) for selected clinical studies. SMM principal duties and responsibilities include:

Study preparation:

• Design and conduct early clinical development studies including phase 2a within planned timelines (supported by an operational team).
• Review and approve study documentation (monitoring plan, statistical analysis plan, contracts, regulatory documents, etc.).
• Coordinate clinical team to set-up and follow the study.
• Ensure proper documentation is provided to the Ethics Committees and Health Authorities.

Study conduct:

• Ensure that the study is scientifically sound and correctly conducted.
• Prepare and review the interim investigator reports.
• Lead the Dose Escalation Meeting and document decision making (for First-in-Human studies).
• Review the Adverse Event reports.

Study validation and reporting:

• Participate in the data review and validation meetings before database lock.
• Review and interpret the results.
• Prepare and distribute the Key Results Memo and prepare/review the Clinical Study Report.

Key Internal/External Relationships:

• Internal contacts: Other TMU departments (mainly PreClinical Safety, Laboratory Sciences, Quantitative Pharmacology, Operations and Evidence Generation & Decision Science), Early Development Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance, Therapeutic Area Research & Development Groups.
• External contacts: Investigators, Clinical Site Services Providers, early phase Clinical Research Organizations, clinical trial vendors, clinical and scientific experts, Key Opinion Leaders, ethics committees, Health Authority representatives.

About You

Minimum Required Qualifications

• M.D. or equivalent
• At least 1 year experience in the design and execution of early development clinical trials (phase 1a/b and 2a) OR at least one year experience in exploratory studies within a pharmaceutical, academia, hospital or CRO setting.
• Postgraduate residency training

Preferred Qualifications:

• M.D./Ph.D
• Laboratory research experience in industry or academia.
• Knowledge and mindset in translational research.
• Broad biomedical knowledge base.
• Able to acquire and apply new technical skills.
• Experience in the conduct of late phase clinical trials.

Soft and technical skills:

• Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
• Demonstrated capability to challenge decisions and status quo with a risk-management approach
• Ability to work within a matrix organization, within CPS, TMU, R&D and beyond e.g. Medical.
• International/ intercultural working skills
• Open-minded to apply new digital and/or AI-driven solutions.

Languages: Fluent in English.

The salary range for this position is:
$206,250.00 - $343,750.00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.